A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07035093Tipo: INTERVENTIONALInicio: 29 de may de 2025Fin estimado: 1 de sept de 2027

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a history of axial-predominant low back pain
Have pain that is restricted to the low back or with a referral pattern limited to the proximal legs
Have a body mass index (BMI) ≥27 kilograms per square meter (kg/m2) at screening
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

Criterios de exclusión

Have a non-axial origin low back pain
Have had botulinum or steroid injections to the spine within 1 year of screening
Have had trigger point injection to the spine within 6 months of screening
Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days prior to screening
Have been taking drugs to promote body weight reduction, including over-the-counter medications, within 90 days prior to screening
Have a prior or planned surgical treatment for obesity
Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes

Intervenciones

drug

Placebo

Administered SC

drug

Retatrutide

Administered SC

Ubicaciones

Investigaciones Medicas Imoba Srl

Buenos Aires, Argentina

RECRUITING

CIPREC

Buenos Aires, Argentina

RECRUITING

Centro Médico Viamonte

Buenos Aires, Argentina

RECRUITING

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina

RECRUITING

Fundación Respirar

Buenos Aires, Argentina

RECRUITING

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Argentina

RECRUITING

Centro Rosarino de Investigaciones Clinicas (CRICs)

Rosario, Argentina

RECRUITING

Instituto Médico Catamarca IMEC

Rosario, Argentina

RECRUITING

Centro de Diagnóstico y Rehabilitación (CEDIR)

Santa Fe, Argentina

RECRUITING

Patrocinadores

PrincipalEli Lilly and Company

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 1-317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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